ANMAT canceled the license of more than 50 drugstores for violating Good Distribution Practices

La ANMAT Arranged the Reduction of the authorization for the interjurisdictional transit of drugs and medicinal specialties to more than 50 drugstores that did not meet the requirements established in current regulations.

The measure was made official through its publication in the Official Bulletin, and is based on the Non-compliance with Good Drug Distribution Practices (BPD) Certificate, required by the ANMAT Provision No. 2069/2018.

This decision has a direct impact on the operations of the companies reached, since It inhibits them from moving drugs between jurisdictions, critically affecting their logistical and commercial capacity.

What does Provision 2069/2018 establish?

Provision 2069/2018 defines the mandatory requirements that drugstores must comply with in order to operate drugs at an interjurisdictional level, including:

• Effective implementation of Good Distribution Practices.
• Adequate conditions of storage, conservation and transport.
• Documentary systems that ensure the full traceability of medications.
• Reliable, complete and auditable records.
• Procedures for managing diversions, complaints and recalls.

El BPD Certificate it is the instrument that accredits such compliance and is essential to maintain the current authorization.

What does the cancellation of the license entail?

The cancellation of the license ordered by ANMAT It is not a minor observation or a preventive warning. In operational terms, it implies that the drugstores reached:

• They cannot perform interjurisdictional transit of medications.
• They are limited to distributing products outside their authorized jurisdiction.
• They are exposed to increased penalties in case of non-compliance.
• Come committed to continuity of your business operation.

In practice, this measure can completely or partially paralyze the activity of a drugstore.

Regulatory compliance and traceability: a growing requirement

The recent license reductions reflect a clear scenario:
regulatory bodies are raising the standard of control and oversight throughout the pharmaceutical supply chain.

The lack of compliance in aspects such as documentation, traceability and process control no longer only translates into observations, but into concrete measures that directly impact the business.

The Role of Technology in Preventing Sanctions

Many of these situations originate in manual processes, dispersed information or non-integrated systems, which make it difficult to maintain regulatory compliance on an ongoing basis.

To have a comprehensive quality management system and traceability allows drugstores and distributors to:

• Ensure ongoing compliance with Good Distribution Practices.
• Centralize and secure regulatory documentation.
• Ensure full traceability of medicines.
• Facilitate ANMAT audits and inspections.
• Detect and correct deviations before they become sanctions.

Quality and compliance as part of the strategy

The disqualification of more than 50 drugstores leaves a strong message for the sector:
regulatory compliance is no longer a formal requirement, but a critical factor of operational continuity.

Investing in quality, traceability and control not only makes it possible to comply with regulations, but protect the operation, reputation and patient safety.

In Verifarma, we accompany drugstores, laboratories and distributors in the implementation of technological solutions that strengthen quality management and ensure compliance with the requirements of ANMAT and international organizations.

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